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A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial.

ABSTRACT: Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes.This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion.This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice.Clinicaltrials.gov NCT01070056.

SUBMITTER: Schoenthaler A

PROVIDER: S-EPMC3264527 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial.

Schoenthaler Antoinette A Luerassi Leanne L Teresi Jeanne A JA Silver Stephanie S Kong Jian J Odedosu Taiye T Trilling Samantha S Errico Anna A Uvwo Oshevire O Sebek Kimberly K Adekoya Adetutu A Ogedegbe Gbenga G

Trials 20111222

<h4>Background</h4>Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-r ...[more]

PMID: 22192273

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Project description:BackgroundEffective hypertension self-management interventions are needed for socially disadvantaged African Americans, who have poorer blood pressure (BP) control compared to others.ObjectiveWe studied the incremental effectiveness of contextually adapted hypertension self-management interventions among socially disadvantaged African Americans.DesignRandomized comparative effectiveness trial.ParticipantsOne hundred fifty-nine African Americans at an urban primary care clinic.InterventionsParticipants were randomly assigned to receive (1) a community health worker ("CHW") intervention, including the provision of a home BP monitor; (2) the CHW plus additional training in shared decision-making skills ("DoMyPART"); or (3) the CHW plus additional training in self-management problem-solving ("Problem Solving").Main measuresWe assessed group differences in BP control (systolic BP (SBP) < 140 mm Hg and diastolic BP (DBP) < 90 mmHg), over 12 months using generalized linear mixed models. We also assessed changes in SBP and DBP and participants' BP self-monitoring frequency, clinic visit patient-centeredness (i.e., extent of patient-physician discussions focused on patient emotional and psychosocial concerns), hypertension self-management behaviors, and self-efficacy.Key resultsBP control improved in all groups from baseline (36%) to 12 months (52%) with significant declines in SBP (estimated mean [95% CI] - 9.1 [- 15.1, - 3.1], - 7.4 [- 13.4, - 1.4], and - 11.3 [- 17.2, - 5.3] mmHg) and DBP (- 4.8 [- 8.3, - 1.3], - 4.0 [- 7.5, - 0.5], and - 5.4 [- 8.8, - 1.9] mmHg) for CHW, DoMyPART, and Problem Solving, respectively). There were no group differences in BP outcomes, BP self-monitor use, or clinic visit patient-centeredness. The Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 18.7 [4.0, 87.3]) and self-efficacy scores (OR [95% CI] 4.7 [1.5, 14.9]) at 12 months compared to baseline, while other groups did not. Compared to DoMyPART, the Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 5.7 [1.3, 25.5]) at 12 months.ConclusionA context-adapted CHW intervention was correlated with improvements in BP control among socially disadvantaged African Americans. However, it is not clear whether improvements were the result of this intervention. Neither the addition of shared decision-making nor problem-solving self-management training to the CHW intervention further improved BP control.Trial registryClinicalTrials.gov Identifier: NCT01902719.

Project description:BACKGROUND:African Americans shoulder significant disparities related to hypertension (HTN), which is a serious public health problem in the city of Detroit, Michigan, where more than 80% of the population is African American. Connectivity through smartphones, use of home blood pressure (BP) monitoring, and newly developed mobile health (mHealth) interventions can facilitate behavioral changes and may improve long-term self-care for chronic conditions, but implementation of a combined approach utilizing these methods has not been tested among African American patients with uncontrolled HTN. Since African Americans are more likely than other racial or ethnic subgroups to utilize the emergency department (ED) for ambulatory care, this presents an opportunity to intervene on a population that is otherwise difficult to reach. OBJECTIVE:The MI-BP app aims to reduce health disparities related to HTN in the community by employing a user-centered intervention focused on self-BP monitoring, physical activity, reduced sodium intake, and medication adherence. We seek to test the efficacy of MI-BP, an mHealth app for HTN self-management, on BP control (primary aim), physical activity, sodium intake, and medication adherence (secondary aim) in African Americans with HTN. This study also seeks to evaluate the cost-effectiveness of MI-BP when compared with usual care methods. METHODS:This is a 1-year randomized controlled trial that will recruit individuals who have uncontrolled HTN from 2 EDs in the city of Detroit, with a planned sample size of 396 randomized participants. To be eligible for inclusion, potential participants must be African American, 25 to 70 years old, previously diagnosed with HTN, have a smartphone compatible with MI-BP, and have uncontrolled BP at triage and on repeat measurement at least 1-hour post triage vitals. Once a participant is deemed eligible, all study procedures and subsequent follow-up visits (8 in total) are conducted at the Wayne State University Clinical Research Service Center. We seek to determine the effect of MI-BP on BP for 1 year (using BP control and mean systolic BP as coprimary outcomes and physical activity, sodium intake, and medication adherence as secondary outcomes) compared with usual care controls. RESULTS:Recruitment for this study began in January 2018. The study will continue through 2021. CONCLUSIONS:As the first of its kind conducted in an ED setting, MI-BP was designed to document the efficacy and acceptability of a multicomponent mHealth approach to help African Americans with uncontrolled BP modify their lifestyle to better manage their HTN. We expect to lay the foundation to sustainably reduce HTN-related health disparities through better integration of multiple behavior self-monitoring and improve outcomes for those who traditionally rely on the ED for chronic disease care. TRIAL REGISTRATION:ClinicalTrials.gov NCT02360293; http://clinicaltrials.gov/ct2/show/NCT02360293. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/12601.

Dataset Information

A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial.

Publications

A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial.

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